510(k) DEN160005
DEN160005 is an FDA 510(k) premarket notification submitted by Stetrix, Inc. for the device "Hem-Avert Perianal Stabilizer". The FDA issued a decision of De Novo Granted on December 19, 2016. The device falls under product code PNU (Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery), a Class II device regulated under 21 CFR 884.5210.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 19, 2016
- Date Received
- January 28, 2016
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery
- Device Class
- Class II
- Regulation Number
- 884.5210
- Review Panel
- OB
- Submission Type
Designed to provide counter-pressure to the perianal region during vaginal childbirth to help reduce the likelihood of Cesarean delivery